MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TNDM BP SHL/XLPE LNR 43OD 26ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number 71325043

Device Problem Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 04/13/2020

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to dislocation and pain.It was reported that the outer cup of bipolar was dislocated when diaplasis occurred.

• Brand Name: TNDM BP SHL/XLPE LNR 43OD 26ID
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 10033360
• MDR Text Key: 190159618
• Report Number: 1020279-2020-01516
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71325043
• Device Lot Number: 19AM15007A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 75000178 / C1921047; 75000178 / C1921047
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR